PIPER, MODEL NUMBER UDS-PIPERB

Device, Cystometric, Hydraulic

LABORIE MEDICAL TECHNOLOGIES, LTD.

The following data is part of a premarket notification filed by Laborie Medical Technologies, Ltd. with the FDA for Piper, Model Number Uds-piperb.

Pre-market Notification Details

Device IDK951805
510k NumberK951805
Device Name:PIPER, MODEL NUMBER UDS-PIPERB
ClassificationDevice, Cystometric, Hydraulic
Applicant LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario),  CA L4v 1x1
ContactFred Buffa
CorrespondentFred Buffa
LABORIE MEDICAL TECHNOLOGIES, LTD. 6415 NORTHWEST DR. UNIT 11 Mississauga (ontario),  CA L4v 1x1
Product CodeFEN  
CFR Regulation Number876.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-04-18
Decision Date1995-07-06

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